Clinical Pharmacology Scientist

☞ Randstad Switzerland

View: 122

Update day: 29-03-2024

Location: Basel Basel-Stadt BS

Category: R & D IT - Software

Industry: Staffing Recruiting

Position: Associate

Job type: Contract

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Job content

Do you want to work in a big pharmaceutical company? Do you have at least 2 years experience in clinical pharmacology? You should then read the following lines!

Our client, based in Basel, is looking for a passionate Clinical Pharmacology Scientist for a 2 years contract with possibility of extension.

General Information
  • Start date: ASAP (01.06)
  • Latest possible start date: 3 months’ notice period considered
  • Workload: 100%
  • Remote/Home Office: Office set up with possibility of some WfH
Your Responsibilities
  • Responsible for the scientific aspects of clinical pharmacology study protocol development, including protocol synopsis, consent form, eCRF and protocol amendments
  • Leads the evaluation of clinical pharmacology data (pharmacokinetics, pharmacodynamics, safety), interacting as required with operational staff and investigators, Data Management, Biostatistics and other partners
  • Leads the ongoing review of study data (e.g. PK, PD and safety) and reviews data outputs for scientific and medical validity and consistency
  • Assists in the preparation of the clinical pharmacology component of the project specific Investigators Brochure
  • Attends and provides science support for investigator meetings and monitor workshops
  • Leads the safety review of clinical pharmacology studies and contribute to serious adverse event (SAE) reconciliation and SAE narratives
  • Primary scientific responsible for writing final study reports
  • Participates in the preparation of the IND and NDA documentation, the dossiers for formal regulatory meetings (e.g. EOP1, EOP2) and materials for use in presentations and responses to regulatory authorities
Your Profile
  • MSc, Pharm D or PhD in pharmaceutical sciences, clinical pharmacology sciences (Post Doc considered).
  • +2 years of experience in industry setting (preferably Pharma) supporting clinical pharmacology studies, NCA data analysis, regulatory filings and medical writing.
  • Clinical research experience, preferably in the pharmaceutical industry, with knowledge of ICH GCP and the drug development process
  • Previous experience / working knowledge of various approaches to PK and PD data analysis: compartmental, curve-fitting, non-compartmental.
  • Experience on software: Phoenix? WinNonlin? (plus Microsoft & Google Suites)
  • Experience of working on, and preferably leading a team matrixed around the scientific and/or clinical study-related tasks.
  • Effective team work and interpersonal skills (globally, internal and externally) including coaching and mentoring
  • Highly effective verbal and written communication/presentation skills in English
  • Shows creativity, critical thinking, initiative and conscientiousness
  • Ability to process information, analyze data, and reach conclusions based on sound reasoning and the rationale based on the risk- benefit assessment and cost-effectiveness.
  • Knowledge of Spotfire? is a plus.
Do not waste any minutes, apply now! We are looking forward to receiving your application.

Please note that only candidates with a valid work permit or who are EU/EFTA citizens will be considered
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Deadline: 13-05-2024

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